MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	100/870/070
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that the flange to a smiths medical portex blue line ultra tracheostomy tube was observed to be damaged following 8 days of use.There were no reported adverse patient effects.
Additional Manufacturer Narrative
Other, other text: h2: additional information received 07/02/2020: see b5 and h1 h3: device evaluation: completed 07/10/2020: one portex tube blue line classic tracheostomy tube from p/n (b)(4) l/n unknown was received in used condition without its original packaging.The sample was visually inspected, at a distance of 12" to 16" and normal conditions of illumination; the connector was found damaged.Relevant documents were reviewed and considered adequate and correct for testing and inspection activities.The most probable cause of the issue is that the product became damaged after it left the smiths medical facility.
Event or Problem Description
Additional information was received indicating that a tube change out was performed.

• Brand Name: PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 10171404
• Report Number: 3012307300-2020-06069
• Device Sequence Number: 2142902
• Product Code: BTO
• UDI-Device Identifier: 15019315038785
• UDI-Public: 15019315038785
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 100/870/070
• Device Catalogue Number: 100/870/070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention